Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073306
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION;TOPICAL Prescription AT No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/28/1995 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2002 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/29/2002 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/30/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

02/04/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/2000 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

01/28/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/23/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/18/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLOTRIMAZOLE

SOLUTION;TOPICAL; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION;TOPICAL Prescription No AT 209815 NOVITIUM PHARMA
CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION;TOPICAL Prescription No AT 074580 TARO
CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION;TOPICAL Prescription No AT 212281 TASMAN PHARMA
CLOTRIMAZOLE CLOTRIMAZOLE 1% SOLUTION;TOPICAL Prescription No AT 073306 TEVA

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